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Evaluation of heart rate lowering effects with ivabradine in patients with angina in the hospital

ESSENTIEL Hospital: observation of exclusive heart rate reduction effects with ivabradine in angina patients in a hospital setting

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN14549448
Enrollment
125
Registered
2023-02-07
Start date
2018-01-05
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease (CAD) and angina Circulatory System

Interventions

This is an observational study. Each investigator recruited 10 patients presenting symptomatic stable coronary artery disease. The decision to prescribe ivabradine was made by the physician independen

Sponsors

Servier Maroc
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria: as per current SmPC 1. Patients 18 years and older 2. Female or male 3. Patients with documented stable coronary artery disease with or without left ventricular dysfunction (LVD); example: with angina, history of revascularization, history of myocardial infarction, or angiographic evidence of at least 70% stenosis of one of the major coronary arteries 4. Patient with stable angina diagnosed more than 6 months ago 5. HR resting >70 bpm 6. Patients inadequately controlled despite an optimal dose of beta-blockers

Exclusion criteria

Exclusion criteria: Exclusion criteria: according to current SmPC 1. Known hypersensitivity to the active substance or any of the excipients 2. Resting heart rate of fewer than 70 beats per minute prior to treatment 3. Cardiogenic shock 4. Acute myocardial infarction 5. Severe hypotension (<90/50 mmHg) 6. Severe liver failure 7. Sick sinus syndrome 8. Atrial sinus block 9. Unstable or acute heart failure 10. Pacemaker-dependent patient (heart rate exclusively imposed by the pacemaker) 11. Unstable angina 12. Third-degree atrioventricular (AV) block 13. Combination with potent cytochrome P450 3A4 inhibitors, such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), protease inhibitors (nelfinavir, ritonavir) or nefazodone 14. Combination with verapamil or diltiazem, moderate CYP 3A4 inhibitors with bradycardic effects 15. Pregnancy, breastfeeding and women of childbearing age not using effective contraception

Design outcomes

Primary

MeasureTime frame
1. HR measured by electrocardiogram at baseline, after 1 month and after 4 months 2. CCS grades determined using the Canadian Cardiovascular Society grading of angina pectoris system at baseline, after 1 month and after 4 months

Secondary

MeasureTime frame
Physician satisfaction assessed by rating the tolerability, efficacy, and effectiveness of ivabradine on a scale of 0 to 5 after 4 months of ivabradine treatment

Countries

Morocco

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026